FDA News Digest March 8, 2004 ______________________________________________________________ THIS WEEK'S NEWS -- FDA Evaluating Latest Study on Estrogen Use in Postmenopausal Women -- FDA to Disclose Application Dates to Help Improve Access to Generics -- New Web Site Is Gateway to Information on FDA-Approved Drugs -- Recalls/Market Withdrawals -- Public Meetings ______________________________________________________________ FDA Evaluating Latest Study on Estrogen Use in Postmenopausal Women FDA is examining the latest results of a major National Institutes of Health study of women taking only estrogen as postmenopausal hormone therapy. The agency will determine if study results -- showing that estrogen-alone therapy increases stroke risk, decreases hip fracture risk, but does not affect heart disease -- warrant changes in estrogen labeling. The study, part of the Women's Health Initiative, included 11,000 healthy postmenopausal women who had hysterectomies. http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01281.html FDA to Disclose Application Dates to Help Improve Access to Generics FDA plans to provide information to help generic drug applicants determine if they are eligible for 180 days of marketing exclusivity, an incentive that helps get generic drugs to market sooner. FDA will now disclose on its Web site the date on which the first complete application is submitted to challenge a brand-name drug patent. The agency will continue its policy of not disclosing the name of the generic company making the submission. http://www.fda.gov/bbs/topics/NEWS/2004/NEW01030.html New Web Site Is Gateway to Information on FDA-Approved Drugs To help patients and consumers get the information they need to make informed choices, FDA has created a Web site with quick access to information about FDA-approved brand-name and generic drugs. Called Drugs @ FDA, the site is a searchable database with information on approved prescription drugs, some over-the-counter drugs, and discontinued drugs. The new site consolidates drug information so users no longer have to visit several FDA Web pages for background on medicines. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/ ______________________________________________________________ RECALLS/MARKET WITHDRAWALS The following products are being recalled for the reasons shown. Go to the linked page for more information. Faaborg model battery-operated patient lifts, distributed by Moving Solutions Inc. (faulty design) http://www.fda.gov/bbs/topics/news/2004/NEW01032.html Running Wolf Trail Mix (undeclared sulfites) http://www.fda.gov/oc/po/firmrecalls/runningwolf03_04.html Springfield brand (8 oz. plastic cups) and El Burrito brand (8 and 11-oz. cups) guacamole (possible Listeria monocytogenes contamination) http://www.fda.gov/oc/po/firmrecalls/elburrito03_04.html SunRidge Farms All-Natural Yogurt Raisins (undeclared almonds) http://www.fda.gov/oc/po/firmrecalls/sunridge03_04.html Turiba Iriss Krejuma candy (undeclared peanuts) http://www.fda.gov/oc/po/firmrecalls/edendeli03_04.html Yake Caramel Toffee (undeclared peanuts) http://www.fda.gov/oc/po/firmrecalls/newworld03_04.html Tianma Sweet Potato (undeclared sulfites) http://www.fda.gov/oc/po/firmrecalls/ckm02_04.html Ginnou Chocolate (undeclared peanuts) http://www.fda.gov/oc/po/firmrecalls/blooming02_04.html Yuexiang Egg Mung Bean Rice Fried Cake (undeclared peanuts) http://www.fda.gov/oc/po/firmrecalls/changwang03_04.html Chalwa candy (undeclared peanuts) http://www.fda.gov/oc/po/firmrecalls/eden03_04.html For a listing of recalls, market withdrawals, and safety alerts from the last 60 days, go to http://www.fda.gov/opacom/7alerts.html ______________________________________________________________ PUBLIC MEETINGS March 17 -- FDA/Drug Information Association Workshop: "Combating Counterfeit Drugs"; Washington, D.C. http://www.diahome.org/Content/Events/04027.pdf For a list of upcoming FDA meetings, seminars, and other public events, go to http://www.fda.gov/opacom/hpmeetings.html. ______________________________________________________________ Thanks for subscribing to FDA News Digest. Our next posting will be March 15. To leave this list at any time, send an e-mail to LISTSERV@xxxxxxxxxxxx In the body of the message, write SIGNOFF FDA-NEWSDIGEST-L
